MAUDE Adverse Event Report: TANDEM DIABETES CARE T:CONNECT MOBILE APP; T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

Model Number	1007111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer went to the emergency room due to low blood glucose (bg) level of 31mg/dl.The customer consumed carbohydrates and was treated with intravenous saline to address bg level.The customer was discharged on (b)(6) 2022 with no permanent injury.Tandem technical support (cts) reviewed pump data logs and determined that the customer requested and delivered a 15 unit bolus via the tandem mobile application.Reportedly, the customer had intended to deliver a 1.5 unit bolus.Cts educated the customer on proper bolus delivery procedure.
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Per tandem's pump user guide, "do not deliver a bolus until you have reviewed the calculated bolus amount on the pump display.If you dose an insulin amount that is too high or too low, this could cause very high or very low blood glucose.You can always adjust the insulin units up or down before you decide to deliver your bolus.".
Additional Manufacturer Narrative
D2b.

• Brand Name: T:CONNECT MOBILE APP
• Common Device Name: T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 15396771
• Report Number: 3013756811-2022-99514
• Device Sequence Number: 5007078
• Product Code: QFG
• UDI-Device Identifier: 90850018992452
• UDI-Public: 90850018992452
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K203234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1007111
• Device Catalogue Number: T:CONNECTMOBILEAPP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic